Merck and Ridgeback drop second FDA emergency sign for COVID-19 antiviral pill


Pfizer wasn’t the only drugmaker to win an early Christmas giveaway from the FDA this year. A day after Paxlovid was blessed as the first oral treatment for COVID-19, molnupiravir from Merck & Co. and Ridgeback Biotherapuetics entered the fray as the second antiviral pill authorized in the United States

Late last week, the FDA approved molnupiravir to treat adults with mild to moderate COVID-19, with emergency clearance specifically intended for patients at high risk of progressing to severe cases of COVID-19. pandemic disease, including hospitalization or death. The agency’s green light also includes patients for whom other authorized COVID-19 treatments “are not accessible or clinically appropriate,” the FDA said in a statement.

Approval comes at the “right time,” wrote Louise Chen, Cantor Fitzgerald analyst, in a recent note to clients. More therapies are needed to supplement vaccinations, especially in light of troubling variants like omicron.

However, molnupiravir may not be as prevalent as Pfizer’s oral antiviral Paxlovid, which Chen’s team attributes to the latter’s superior safety and efficacy profile. Still, the go-ahead for molnupiravir is “good news” for Merck, and both drugs will likely be used to help “flatten the curve,” Chen said.

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The FDA emergency sign comes with a list of warnings. First, patients should start taking the antiviral “as soon as possible” after a diagnosis of COVID-19, and at most within five days of the onset of symptoms. The drug is not authorized for pre- or post-exposure prevention or for the initiation of treatment in hospitalized patients, as the benefit of the drug was not observed in this group.

The antiviral cannot be used in patients under the age of 18 because it can affect the growth of bone and cartilage, the FDA has said. Pregnant people should also not take molnupiravir: Animal reproduction studies suggest that the antiviral may harm the fetus.

Molnupiravir works by introducing errors into the genetic code of the SARS-CoV-2 virus, which in turn prevents the virus from replicating. The drug is only allowed for use over five days. Patients taking the medicine are given four 200 mg capsules every 12 hours, for a total of 40 capsules over a five day period.

The FDA has blessed an interim analysis of the late-stage MOVe-OUT trial, which pitted molnupiravir against placebo in outpatients who were not vaccinated against COVID-19. Patients had to have a lab-confirmed COVID-19 infection, their symptoms had to start within five days of randomization, and they had to have at least one risk factor for poor disease outcomes, such as heart disease or diabetes, Merck said in an outing.

With a pool of 762 patients, the interim analysis showed that molnupiravir “significantly” reduced the risk of hospitalization and death up to day 29 of the study. In the molnupiravir group, 7.3% of patients were hospitalized or died, compared to 14.1% in the placebo arm.

Beyond the interim analysis, 9.7% of people on placebo were hospitalized or died, compared to 6.8% in the molnupiravir cohort. In total, there were nine deaths in the placebo group versus one in the molnupiravir arm.

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“Because we recognized the promise of molnupiravir early on, Merck invested at risk and we are implementing an unprecedented global access strategy so that the now approved molnupiravir can be made available to patients here in the United States. and around the world faster and more equitably than ever before, ”Merck CEO Robert Davis said in a statement.

The New Jersey-based drug maker said Thursday it plans to start shipping molnupiravir to pharmaceutical distributor AmerisourceBergen “within days.” Merck currently has a $ 2.2 billion deal with the US government to provide some 3.1 million courses of the drug.

Indeed, global access has been a “priority” for Merck and Ridgeback since the beginning of their collaboration. They also take advantage of tiered pricing based on the ability of governments to fund health care. Perhaps more importantly, Merck and Ridgeback have entered into licensing agreements with certain generic manufacturers and the Medicines Patent Pool to put generic molnupiravir on sale in more than 100 low- and middle-income countries.

Merck plans to produce 10 million courses of the drug by the end of the year, with plans to deliver at least 20 million courses in 2022. Outside the United States, Merck and Ridgeback have committed to supply their drug to more than 30 countries, including Australia, Canada, Korea, Japan, Thailand and United Kingdom

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